Quality Concepts and ISO 9001:2015 QMS Awareness: Certification/Registration to ISO 9001:2015 QMS - ...

Quality Concepts and ISO 9001:2015 QMS Awareness: Certification/Registration to ISO 9001:2015 QMS - ...: Certification/Registration to ISO 9001:2015 QMS - Part 3 Certification Procedure for QMS Certification Keshav Ram Singhal Generally ...

Quality Concepts and ISO 9001:2015 QMS Awareness: Certification/Registration to ISO 9001:2015 QMS - ...

Quality Concepts and ISO 9001:2015 QMS Awareness: Certification/Registration to ISO 9001:2015 QMS - ...: Certification/Registration to ISO 9001:2015 QMS - Part 2 Selecting a Certification Body and Applying for Certification/Registration Kes...

Quality Concepts and ISO 9001:2015 QMS Awareness: Certification/Registration to ISO 9001:2015 QMS - ...

Quality Concepts and ISO 9001:2015 QMS Awareness: Certification/Registration to ISO 9001:2015 QMS - ...: Certification/Registration to ISO 9001:2015 QMS - Part 1 Taking the decision to implement ISO 9001:2015 QMS and its certification Kesha...

Quality Concepts and ISO 9001:2015 QMS Awareness: Training Handbook on 'ISO 9001:2015 QMS Implementa...

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Training Handbook on 'ISO 9001:2015 QMS Awareness'

Training Handbook on 'ISO 9001:2015 QMS Awareness'


ISO 9001:2015 QMS standard has replaced the earlier version ISO 9001:2008 QMS standard. Organizations are now required to upgrade their quality management systems (QMS) according to ISO 9001:2015 QMS standard before the transition period expires.

I have designed and developed a Training Handbook on ISO 9001:2015 QMS Awareness, for the benefit of the management executives, personnel involved in ISO 9001 QMS implementation, internal auditors and individuals, who are interested to upgrade their knowledge.

Contents of the Training Handbook are:
# 01 - An introduction on 'ISO 9001:2015 QMS Awareness' Training
# 02 - Introduction - Historical background, Standard Development Timeline for ISO 9001:2015
# 03 - Overview - Foreword, Introduction, QMS - Requirements Clauses, Scope, Normative references, Terms and definitions
# 04 - Context of the organization
# 05 - Leadership
# 06 - Planning
# 07 - Support
# 08 - Operation
# 09 - Performance evaluation
# 10 - Improvement
# 11 - Transition Planning
# 12 - Developing and Implementing ISO 9001:2015 QMS - This includes step-by-step process to develop and implement ISO 9001:2015 QMS. Very useful for organizations.
# 13 - Risk-based Thinking - An integral part of ISO 9001:2015 QMS
# 14 - ISO 9001:2015 QMS - Understanding the process approach and PDCA
# 15 - ISO 9001:2005 - Quality Management Principles
# 16 - Change Management in ISO 9001:2015
# 17 - Adding Value to the Audit
# 18 - Post-training test details

If you are interested to see the Preview of the Training Handbook, please send me an email. I will send a copy of the same.

Thanking you,

Keshav Ram Singhal

Email
keshavsinghalajmer@gmail.com
or
krsinghal@rediffmail.com

One more request - Please share this message with friends in your network, so that more people may know about the Training Handbook.

TRAINING ON 'ISO 9001:2015 QMS AWARENESS'

AN OPPORTUNITY TO LEARN AND UPDATE YOUR KNOWLEDGE
ON
'ISO 9001:2015 QMS AWARENESS'



LEARNING OBJECTIVES


UNDERSTAND THE IMPACTS OF NEW STANDARD ON YOUR QMS

After attending the training you will be able to understand KEY CHANGES that affect your organization and your quality management system implementation, including the following -
• Structure and terminology
• Context of the organization
• Risk-based thinking
• Knowledge management
• Role of top management
• Management representative's role?
• Documentation impact and requirements for documented information
• Internal audit
• Understanding ISO 9001:2015 QMS requirements
• Transition planning guidance
• Implementation Guidance


CLICK HERE to see more details.

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Certification Bodies

Certification Bodies Operating in India and Neighbouring Countries

The editor of this blog is collecting details of certification bodies operating in India and Neighbouring Countries. Please send details (name, address, email, website, etc.) by email to:
keshavsinghalajmer@gmail.com
or
krsinghal@rediffmail.com.

Thanks,

Keshav Ram Singhal

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An Overview on International Standard on 'Quality Management - Guidelines for Training'

- Keshav Ram Singhal


International Organization for Standardization (ISO) had published an international standard on 'Quality management - Guidelines for training' in the year 1999. ISO 10015:1999 is a standard, that provides guidelines to assist organizations and their personnel when addressing issues related to training. This standard may be applied whenever guidance is needed with reference to 'education' and 'training' within ISO 9000 family of standards. A number of internal and external factors (such as changes in markets, technology, innovation, customer requirements, etc.) may affect performance of an organization's personnel, for which the organization needs to analyze its competence-related needs.



ISO 10015:1999 provides guidance that can help an organization to:
- identify and analyze training needs
- design and plan the training needs
- evaluate training outcomes
- monitor and improve the training process

Guidelines mentioned in ISO 10015:1999 cover the development, implementation. maintenance, and improvement of strategies and systems for training. These guidelines are meant for all types of organization, regardless of type, size and the produced products or services. Training providers may also use ISO 10015:1999 standard to address training needs of their personnel. ISO 10015:1999 mentions four-stage process of training, which are (i) Define training needs, (ii) Design and plan training, (iii) Provide for training, and (iv) Evaluate training outcomes.



ISO 10015:1999 standard has following clauses:

1 - Scope
2 - Normative reference
3 - Terms and definitions - This clause define related terms: (i) Competence, (ii) Training.

4 - Guidelines for training
4.1 - Training: A four-stage process
4.1.1 - General
4.1.2 - Purchase of training-related products and services
4.1.3 - Involvement of personnel

4.2 - Defining training needs
4.2.1- General
4.2.2 - Defining needs of the organization
4.2.3 - Defining and analysing competence requirements
4.2.4 - Reviewing competence
4.2.5 - Defining competence gaps
4.2.6 - Identifying solutions to close the competence gaps
4.2.7 - Defining the specifications for training needs

4.3 - Designing and planning training
4.3.1 - General
4.3.2 - Defining the constraints
4.3.3 - Training methods and criteria for selection
4.3.4 - Training plan specification
4.3.5 - Selecting a training provider

4.4 - Providing for the training
4.4.1 - General
4.4.2 - Providing support
4.4.2.1 - Pre-training support
4.4.2.2 - Training support
4.4.2.3 - End-of-training support

4.5 - Evaluating training outcomes
4.5.1 - General
4.5.2 - Collecting data and preparing an evaluation report

ISO 10015:1999 standard provides five tables mentioning inputs, process, outputs and record:
Table A.1 - Defining training needs
Table A.2 - Designing and planning the training
Table A.3 - Providing for the training
Table A.4 - Evaluating training outcomes
Table A.5 - Monitoring and improving training needs

ISO 10015:1999 standard is priced Swiss franc 88 and can be obtained from the Central Secretariat of International Organization for Standardization (ISO) - Website: iso.org.

On the recommendation of the Quality Management Sectional Committee (MSD 2) and approval of the Management and Systems Division Council, Bureau of India Standards (BIS) had adopted ISO 10015:1999 as Indian Standard and published identical Indian Standard IS/ISO 10015:1999 and reaffirmed in 2004, which can be obtained from the sales counter of BIS (Website - bis.org.in) at the price within India of Indian Rupees 340. Price are subject to change.

Please note: The writer of this article is available for 'ISO 10015 Awareness' training as a trainer and organizations can contact mentioning their requirements.

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A Tool for Improving Creativity - "TRIZ Crossover QMS"

A Tool for Improving Creativity - "TRIZ Crossover QMS"

- Keshav Ram Singhal
Centre Coordinator, National Centre for Quality Management, Ajmer Centre

Andrej Trebar, retired electronic engineer from Slovenia and a member of (i) ASQ (American Society for Quality advancement), and (ii) SZKO (Slovenian association for quality and excellence), has developed an application titled "TRIZ Crossover QMS", a tool for improving creativity at group/team quality improvement workshop. The application is available at Google Play Store. The tool is based on Alshuller's Theory of Inventive Problem Solving and merges inventive principles with quality management concepts and tools, thus enabling quality practitioners to boost his creativity when solving difficult problems. This is an application for android based smart phones and tablets. This application provides an algorithm for problem solving and an algorithm for evolution of products, processes and systems. It provides basic TRIZ fundamentals and analytical methods that create a new mindset needed to enable the quality practitioner to improve management systems including QMS.

Andrej Trebar

It is easy to install "TRIZ Crossover QMS" application and you can see for yourself how it operates and what added value it can bring to its user.

What is TRIZ?

TRIZ is a Russian theory of inventing problem (task) solving. TRIZ is the abbreviation of “теория решения изобретательских задач” translated into English "Theory of Inventing Problem (Task) Solving." This theory was developed by Genrikh Saulovich Altshuller and his colleagues in the former Soviet Union between 1946 and 1985. TRIZ is a theory describing tools, techniques and databases together with an algorithmic process of finding inventive solutions to various types of tasks and problems. It is really interesting that TRIZ allows algorithmic solutions to inventive problems (tasks) while maintaining the freedom of choice and human activity.

Genrikh Saulovich Altshuller (15 October 1926 - 24 September 1998) was a Soviet engineer, inventor, scientist, journalist and writer. He founded the Azerbaijan Public Institute for Inventive Creation, and was the first President of the TRIZ Association. He also wrote science fiction under the pen-name Genrikh Altov.

TETRIS, a project developed by international players, is also a way of teaching TRIZ. It's website, provides useful information on TRIZ that mentions, "In comparison with psychological methodology to boost creativity TRIZ allows a better problem definition, takes advantage of solution also from other fields, helps in overcoming compromises and move towards the ideal final result." It further states, "The TRIZ approach is quite different from other problem solving methodologies. In most cases the problem you’re facing now, has been already faced by many other people at different times, at different places and in different situation. TRIZ allows to connect your problem to a standard problem and so suggesting a standard solution which provide you the direction to follow to find out the best solution for your problem overriding your psychological inertia. But also in case you must deal with a completely new problem, ARIZ (the algorithm including up-to-date TRIZ tool in a structured sequence) will provide you an effective path to find out the best solution."

TRIZ Cards

CX-TRIZ cards are very effective tool for overcoming psychological inertia and finding solutions using already available resources. These cards were developed on the basis of TRIZ. Letter X denotes the process, so CX-TRIZ cards are intended to seek solutions for a process. There are other cards, such as CQ-TRIZ, CS-TRIZ, CD-TRIZ. CQ-TRIZ cards are intended to seek solutions for inventive problem-solving in the field of quality management. CS-TRIZ cards are intended to seek solutions for inventive problem solving in marketing and sales. CD-TRIZ cards are intended to seek solutions for inventive problem solving when designing products and services.

TRIZ cards are based on TRIZ inventive principles. Generally a set contains forty cards. Each card printed with a graphic presentation of a principle with example and explanation (on the back side of the card). The inventive principles are used as a brainstorming tool.

Guided brainstorming

Andrej Trebar says, "When in need of ideas for a solution to a particular problem or to develop new products or services, we can use the method of brainstorming. If possible we organize a brainstorming session with individuals capable of generating creative ideas needed to solve the problem. Often it turns out that employees do not have fresh ideas. In this case, we find ourselves in a situation where we are alone and urgently need to seek ideas to solve our problems."

TRIZ cards are able to guide human thinking in line with chosen algorithm, thus able to solve problems towards an optimum solutions taking into account the 40 inventive principles to find solutions to given problem. A set of TRIZ cards is an important resource which one can use to try to solve a problem. For finding the solution, one or more inventive principles should be selected and combine them in a method.

It is often difficult to review all 40 cards in a given time. S. Fayer suggested grouping of these 40 cards in four groups as under:

Group #1: Dealing with Quality, Quantity, Structure and Form
Related Inventive principles: 1, 2, 3, 4, 7, 14, 17, 30, 31, 40

Group #2: Dealing with adverse factors
Related Inventive principles: 9, 10, 11, 12, 13, 19, 21, 23, 24, 26, 33, 39

Group #3: How to improve efficiency and ideal situation
Related Inventive Principles: 5, 6, 15, 16,20, 25, 26, 34

Group #4: Using Scientific effects, fields and substances
Related Inventive Principles: 8, 18, 28, 29, 32, 35, 36, 37, 38, 30, 31, 40

Guided Brainstorming Process Steps

Guided brainstorming has following process steps:

Step #1 - Define a problem.
Step #2 - Find out - what to improve, what may worsen.
Step #3 - Select a group of inventive principles related to the problem.
Step #4 - Study each card with inventive principle.
Step #5 - If certain card appears to be useful. Study the card carefully. Understand the example and explanation given on the card.
Step #6 - Select inventive principle cards that may be helpful in solving the problem.
Step #7 - Collect ideas from team members and formulate proposal of solution.

TRIZ Inventive Principles

40 TRIZ inventive principles are related to: (1) Segmentation, (2) Taking out, (3) Local quality, (4) Asymmetry, (5) Merging, (6) Universality, (7) Nesting, (8) Anti-weight, (9) Preliminary counter action, (10) Preliminary action, (11) Beforehand cushioning, (12) Equipotentiality, (13) Inversion (the other way round), (14) Spheroidality - Curvature, (15) Dynamics, (16) Partial or excessive actions, (17) Another dimension, (18) Mechanical vibration, (19) Periodic action, (20) Continuity of useful action, (21) Skipping,(22) "Blessing in disguise' or 'Turn Lemons into Lemonade', (23) Feedback, (24) Intermediary, (25) Self-service, (26) Copying, (27) Cheap short-life objects, (28) Mechanics substitution, (29) Pneumatics and hydraulics, (30) Flexible shells and thin films, (31) Porous materials, (32) Colour changes, (33) Homogeneity, (34) Discarding and recovering, (35) Parameter changes, (36) Phase transition, (37) Thermal expansion, (38) Strong oxidants - Boosted interactions, (39) Inert atmosphere, and (40) Composite materials.

In addition to the above, there are separation principles, 4 sets of improvement inventive principles and 39x39 contradiction matrix.

Installing 'TRIZ Crossover QMS'

It is easy to install "TRIZ Crossover QMS" application developed by Andrej Trebar. You can search the application by opening Google Play Store and then you can install. It takes a few minutes to install. After installing the application, you can see for yourself its operation and the value it adds to you.

Courtesy sources:
- http://www.creativ-plus.si/triz/Instructions%20for%20use%20TRIZ%C3%97QMS%20application.pdf
- http://www.creativ-plus.si/triz/CX-TRIZ%20Users%20Manual.pdf
- https://play.google.com/store/search?q=QMS&hl=en
- http://www.tetris-project.org/index.php?option=com_content&view=article&id=47&Itemid=30&lang=en
- Emails from Mr. Andrej Trebar

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ISO/FDIS 9001:2015 EXPECTED SOON

As per the latest information, the Final Draft International Standard (FDIS) for forthcoming ISO 9001:2015 QMS standard is expected to be issued in July 2015.

More information/relevant articles may be seen in the blog on 'Forthcoming ISO 9001:2015 QMS Awareness'.

- Keshav Ram Singhal

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Verification and Validation in QMS

Verification and Validation in QMS

People generally ask difference in verification and validation. These are two terms having the same objective 'confirmation' through the provision of objective evidence. ISO 9000:2005 has defined both terms as under:

Verification: Verification is the conformation through the objective evidence that specified requirements have been fulfilled.

Validation: Validation is the confirmation through the objective evidence that the requirements for a specific intended use or application have been fulfilled.

Verification ensures that the output (or the product) has satisfied the input requirements, the requirements that are specified. Validation ensure that the output (or the product) is capable of fulfilling requirements for the specified application or intended use.



There may be situations where the resulting the output (or the product) during product realization process cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become known only after the product is in use or the service has been delivered. In such situations, validation of processes ensures that the output (or the product) is fit for the intended use. Validation is required where the output (or the product) cannot be verified without damaging or destroying the output (or the product). For example it is difficult to verify the welding output or a product like a gun bullet or a tear-shell.



Verification is done by monitoring and measurement that the output meets input requirements.

Validation of a process requires establishment of certain arrangements, such as defined criteria for review of process, defined criteria for approval of the process, approval of the equipment, approval of qualification of people, use of specific methods, use of specific procedures, requirements for records and re-validation.

Accordingly, we can say that the verification is the confirmation that the right product is produced in accordance with its specifications. And validation is confirmation that the right product is produced that will meet expected results. Verification is the evaluation of whether or not the output (or the product) complies stated requirements. And validation is assurance that the output (or the product) meets the needs what is expected.

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